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NCT01103128 · ClinicalTrials.gov registry record
Validation of a Mouse Model of Pancreatic Carcinogenesis
A clinical trial, sponsored by Columbia University.
- Terminated
- Registry status
- 450
- Enrollment target
NCT01103128: Clinical Trial study, sponsored by Columbia University.
NCT01103128 is a clinical trial that was terminated before completion, run by Columbia University. The registered enrollment target is 450 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01103128 was terminated before completion, sponsored by Columbia University.
- TERMINATED
- Registry status
- 450 participants
- Enrollment target
Study Summary
The primary aim of this study is to determine if mutations of BRCA1 and BRCA2 result in different precancerous pathways to pancreatic ductal adenocarcinoma (PDAC), as suggested in our validated mouse model. Genomic DNA will be isolated on normal tissue obtained from patients who underwent pancreatic resection for PDAC, intraductal papillary mucinous neoplasm (IPMN) or mucinous cystic neoplasm (MCN). Tissue will be examined for the three most common founder mutations in Ashkenazi Jews. In the cases in which BRCA1 or BRCA2 mutations are found, heterozygote normal and abnormal tissue will be examined to look for mutations in the other BRCA1 or BRCA2 allele. The interaction between other cancer causing genes with BRCA1/2 will also be evaluated by comparing the sequences of the other genes in pre-cancerous lesions. We hypothesize that BRCA1- and BRCA2-mediated pancreatic ductal adenocarcinoma progresses through the PanIN route, as seen in both BRCA1 and BRCA2 murine models of pancreatic cancer. We further hypothesize that BRCA1 mutations may enable an additional pre- neoplastic pathway through MCN, and that IPMN may embody yet another pre- neoplastic pathway.
Primary Outcome
The primary aim is to determine if germline mutations of BRCA1 and BRCA2 result in different pre-neoplastic pathways to pancreatic cancer, as seen in our murine model. Genomic DNA will be isolated on normal tissue obtained from patients who underwent pancreatic resection for pancreatic cancer, IPMN or MCN. Tissue will be genotyped for the three most common founder mutations in Ashkenazi Jews. In the cases in which BRCA1 or BRCA2 mutations are found, heterozygote normal and abnormal tissue will b
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2009-03 |
| Est. Completion | 2013-05 |
Why NCT01103128 stopped before completion
NCT01103128 is an observational study that tracks outcomes without assigning an intervention. The registered 450 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01103128 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01103128 about?
NCT01103128 is a clinical study titled "Validation of a Mouse Model of Pancreatic Carcinogenesis". The primary aim of this study is to determine if mutations of BRCA1 and BRCA2 result in different precancerous pathways to pancreatic ductal adenocarcinoma (PDAC), as suggested in our validated mouse model. Genomic DNA will be isolated on normal tissue obtained from patients who underwent pancreatic...
What is the current status of trial NCT01103128?
This trial is currently terminated. The enrollment target is 450 participants. The study started on 2009-03. Estimated completion is 2013-05.
Who is sponsoring clinical trial NCT01103128?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
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